The following data is part of a premarket notification filed by Possis Medical, Inc. with the FDA for Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model Xpeedior 120.
| Device ID | K061951 |
| 510k Number | K061951 |
| Device Name: | ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL XPEEDIOR 120 |
| Classification | Catheter, Embolectomy |
| Applicant | POSSIS MEDICAL, INC. 9055 EVERGREEN BLVD., N.W. Minneapolis, MN 55433 -8003 |
| Contact | Frank B Freedman |
| Correspondent | Frank B Freedman POSSIS MEDICAL, INC. 9055 EVERGREEN BLVD., N.W. Minneapolis, MN 55433 -8003 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-10 |
| Decision Date | 2006-11-22 |
| Summary: | summary |